Home NDC 75834-338-01 DICLOFENAC POTASSIUM
Product NDC 75834-338
Requested package NDC 75834-338-01
11-digit product format 758340338
Labeler code 75834
Product ID 75834-338_5ebcae0a-9abb-5d2f-e063-6294a90a8a4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac potassium
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA217010
Marketing category ANDA
Marketing start 2025-12-15
Substance DICLOFENAC POTASSIUM
Active strength 50 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217010-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2025-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217010-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A217010-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2025-08-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217010-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2025-08-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217010-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2025-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217010-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2025-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217010-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2025-08-29 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217010-001 DICLOFENAC POTASSIUM 50MG FOR SOLUTION / ORAL AB 2025-08-29 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DICLOFENAC POTASSIUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC POTASSIUM 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L4D5UA6CB4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859063 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75834-338-01 DICLOFENAC POTASSIUM 1 in 1 PACKET POWDER, FOR SOLUTION 1 2 75834-338-02 DICLOFENAC POTASSIUM 9 in 1 CARTON POWDER, FOR SOLUTION 9 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 75834-338-01 75834033801 1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01) 2025-12-15 No No Current